Multiple Myeloma Clinical Trial
Official title:
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
Verified date | February 2011 |
Source | Nordic Myeloma Study Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Treatment demanding multiple myeloma - Refractoriness to melphalan - Acceptance of rules for prevention of pregnancy Exclusion Criteria: - Previous treatment with bortezomib, thalidomide, or lenalidomide - Sensory neuropathy grade III or neuropathic pain grade II - Severe concomitant disorder, e.g. other malignancy or severe heart disease - Transformation to plasma cell leukemia or aggressive lymphoma - Frequent visits for bortezomib injections not feasible - Anticipated non-adherence to study protocol - Pregnancy - Anticipated non-adherence to rules for prevention of pregnancy - Severe thrombocytopenia (Thrombocyte count less than 25000/microliter) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Ålborg university Hospital | Aalborg | |
Denmark | Århus University Hospital | Århus | |
Denmark | Herlev University Hospital | Herlev | |
Denmark | Rigshospitalet | Koebenhavn | |
Denmark | Odense University Hospital | Odense | |
Norway | Diakonhjemmet | Oslo | |
Norway | Ullevål Sykehus | Oslo | |
Norway | Stavanger Universitetssykehus | Stavanger | |
Norway | Trondheim University Hospital | Trondheim | |
Sweden | Falun Hospital | Falun | |
Sweden | Gävle Hospital | Gävle | |
Sweden | Sahlgrenska University Hospital | Göteborg | |
Sweden | Helsingborg Hospital | Helsingborg | |
Sweden | Lidköping Hospital | Lidköping | |
Sweden | Lund University Hospital | Lund | |
Sweden | Malmö University Hospital | Malmö | |
Sweden | Mölndal hospital | Mölndal | |
Sweden | Örebro University Hospital | Örebro | |
Sweden | Örnsköldsvik Hospital | Örnsköldsvik | |
Sweden | Skövde Hospital | Skövde | |
Sweden | St Göran Hospital | Stockholm | |
Sweden | Sundsvall Hospital | Sundsvall | |
Sweden | Uddevalla Hospital | Uddevalla | |
Sweden | Norrland University Hospital | Umeå | |
Sweden | Uppsala University Hospital | Uppsala | |
Sweden | Västerås Hospital | Västerås | |
Sweden | Växjö Hospital | Växjö |
Lead Sponsor | Collaborator |
---|---|
Nordic Myeloma Study Group |
Denmark, Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | Not specified | No | |
Secondary | Response rate | Not specified | No | |
Secondary | Response duration | Not specified | No | |
Secondary | Time to start of other treatment | Not specified | No | |
Secondary | Toxicity | Not specified | Yes | |
Secondary | Quality of life | Not specified | No | |
Secondary | Response rate after cross-over | Not specified | No | |
Secondary | Response duration after cross-over | Not specified | No |
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